Laboratorní stojánky na zkumavky
Laboratorní stojánky na kádinky
Transportní boxy na zkumavky
Jednorázové roušky
Reagencie
Izolace DNA/RNA
Enzymy
DNA elektroforéza
Pufry a roztoky
qPCR
Inhibitor RNAse
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- Úvod
- Reagencie
- Pufry a roztoky
- WFI Quality Water, 1 l
WFI Quality Water, 1 l
- Novinka
- Kompletní specifikace
- WFI Quality Water, 1 l1 200 Kč/ ks
Zrychlete výrobu biologických léčiv s vysoce kvalitním řešením, které splňuje přísné normy USP a Ph. Eur. standardy
Pouze pro výzkumné účely.
Water for Injection (WFI) Quality Water, Animal-derived component-free, meets the most stringent United States Pharmacopoeia (USP) and/or European Pharmacopoeia (Ph. Eur.) compendial grade specifications. Manufactured in a ISO 13485:2016 and GMP-certified facility, located in Boecillo, Valladolid (Spain), following GMP compliant procedures to ensure the highest quality standards. It provides you the confidence to achieve exceptional results, with unparalleled purity and reliability with a secure supply chain.
Advantages & Features
- Reliable: manufactured in an ISO 13485:2016 and GMP-certified facility to guarantee lot-to-lot consistency.
- Versatility Empowered: caters to a wide range of applications inside Manufacturing and Research.
- High Purity: due additional steps to eliminate impurities, offering low levels of endotoxins, and microbial contaminants.
- Quality Guaranteed: CoA for each lot of products manufactured supplied upon request.
- Supply Chain Guaranteed: due our strategic location, and deep expertise managing regulatory agencies and shipping globally.
- Increase process Efficiency and Reduce Costs: improve efficiency and reduce QC testing with larger batch volumes, reduce cycle times with just-in-time solutions and capacity constraints.
- Highly experienced Regulatory and Technical expertise: that eliminates raw material risks and batch-to-batch inconsistencies.
Specifications
| Test | Specification /Units | Method references |
| Appearance | clear and colourless liquid | Ph. Eur. 2.2.1; 2.2.2 and 2.9.20. |
| pH | 5.0 – 7.0 | Ph Eur 2.2.3 |
| Conductivity | < 5 µS·cm | Ph. Eur. 2.2.38. |
| Bacterial endotoxins | < 0.25 EU/mL | Ph. Eur. 2.6.14 |
| Bioburden | < 0.1 CFU/mL | Ph. Eur. 2.6.12 |
Includes
Includes for 1L:
-1,000 mL of WFI Quality Water served in PET Bottle.
Includes for 20L:
-20L of WFI Quality Water served in a graduated square container.
Includes for 200L:
-200L of WFI Quality Water served in Single-use container with Plastic Drum.
To know more about our Packaging or request a different one, please Contact us.
Applications
WFI Quality Water, is a versatile solution designed for a wide range of Further Manufacturing and Research applications:
- Buffer Preparation.
- Cell Culture, supplements, and salt solutions Hydration.
- Reconstitution and rehydration of product during synthesis.
- Rinsing of primary packaging, production vessels, equipment, and room surfaces.
Quality Control
Manufactured in an ISO 13485:2016 and GMP-certified facility, located in Boecillo, Valladolid (Spain), under ISO9001:2016 procedures to ensure the highest quality standards. Our processes include:
- Batch-to-batch consistency.
- Facilities audited regularly Quality audits.
- Lot specific CoAs and QA review previously to release a product.
- Material traceability, documented procedures and documented employee training.
- Equipment maintenance and monitoring records.
